The EASE-IT CT Registry

Institut für Pharmakologie und Präventive Medizin

Status: Enrolling

Conditions: Transcatheter Aortic Valve Implantation (TAVI)

Treatments: Other: Streamlining of the pre-procedural patient pathway

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05750173

EASE-IT CT

Details and patient eligibility

About

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

Full description

Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease).

ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost.

CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts.

But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.

Enrollment: 150 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Investigational CTA-only Cohort

• Consecutive adult patients ≥ 75 years
• Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family
• Ability to undergo CTA
• Patient is scheduled to undergo a 30 Day and 3 Months follow-up

CTA+ICA control Cohort

• Consecutive adult patients ≥ 75 years
• Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis
• Ability to undergo CTA and ICA

Exclusion criteria

investigational CTA-only Cohort

• Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50%
• Any prior coronary revascularization / prior aortic valve replacement
• Life expectancy below 12 months
• Lack of informed consent / data protection statement

CTA+ICA control Cohort

• Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline
• Any prior coronary revascularization / prior aortic valve replacement
• Life expectancy below 12 months
• Lack of informed consent / data protection statement

Trial design

150 participants in 2 patient groups

Investigational CTA-only cohort

Description:

100 consecutive patients that are not already diagnosed with significant (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) and who have not previously undergone coronary revascularisation.

Treatment:

Other: Streamlining of the pre-procedural patient pathway

CTA+ICA control cohort

Description:

At least 50 consecutive patients who have not already been diagnosed with significant (≥50%) LM / proximal LAD stenosis an who have not previously undergone conronary revascularisation and will undergo CTA. If LM / proximal LAD stenosis of ≥50% can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group.

Treatment:

Other: Streamlining of the pre-procedural patient pathway